Duns Number:187502109
Device Description: XL, Hip 8-Flute Pear Bur. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375- XL, Hip 8-Flute Pear Bur. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight
Catalog Number
0385-953-008
Brand Name
Formula
Version/Model Number
0385953008
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFF
Product Code Name
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
7431c78f-cf39-4c7a-8bd0-3a378eafc01d
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2018
Package DI Number
37613327055192
Quantity per Package
5
Contains DI Package
07613327055191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |